| Trial ID: | L0575 |
| Source ID: | NCT05082584
|
| Associated Drug: |
Vadadustat
|
| Title: |
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease Naive to Erythropoiesis-Stimulating Agents
|
| Acronym: |
CORRECTION
|
| Status: |
SUSPENDED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anemia of Chronic Kidney Disease
|
| Interventions: |
DRUG: Vadadustat
|
| Outcome Measures: |
Primary: Mean Change in Hemoglobin (Hb) Values Between Baseline and the Primary Evaluation Period (Average Hb From Weeks 21 to 28), Baseline; Weeks 21 to 28 | Secondary: Time to Achieve First Hb Levels ≥10.0 grams/deciliters (g/dL), Up to Week 52|Number of Participants With Mean Hb Values Within the Target Range During the Primary Evaluation Period, From Week 21 to Week 28|Number of Participants With Mean Hb Values Within the Target Range During the Extension Period, From Week 29 to Week 52|Number of Participants With Treatment-emergent Adverse Events and who Discontinued From the Study due to Adverse Events, Up to Week 56|Maximum Observed Plasma Concentration (Cmax) of Vadadustat and its Metabolites, Pre-dose and post-dose at intermediate time points up to 28 weeks|Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC 0-t) of Vadadustat and its Metabolites, Pre-dose and post-dose at intermediate time points up to 28 weeks|Time to Reach Cmax (Tmax) of Vadadustat and its Metabolites, Pre-dose and post-dose at intermediate time points up to 28 weeks|Terminal Elimination Half-Life (t1/2) of Vadadustat and its Metabolites, Pre-dose and post-dose at intermediate time points up to 28 weeks|Change From Baseline in Serum Erythropoietin (EPO), Pre-dose and post-dose at intermediate time points up to 28 weeks|Change From Baseline in Reticulocyte Count, Pre-dose and post-dose at intermediate time points up to 28 weeks|Change From Baseline in Hb levels, Pre-dose and post-dose at intermediate time points up to 28 weeks
|
| Sponsor/Collaborators: |
Sponsor: Akebia Therapeutics
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE3
|
| Enrollment: |
71
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2025-01
|
| Completion Date: |
2026-10
|
| Results First Posted: |
|
| Last Update Posted: |
2023-10-10
|
| Locations: |
Research Site, Hackensack, New Jersey, 07601, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05082584
|
